H. Pylori Antigen Rapid Test Card

タイトルまたは説明

H. Pylori Antigen Rapid Test Card
Intended use
The Helicobacter pylori Ag Rapid test is a lateral flow
chromatographic immunoassay for the qualitative detection of H.pylori antigen in human faecal.It is intended for use in evaluating the serologic status to H.pylori.
Introduction
Helicobacter pylori is a spiral bacterium cultured from human gastric mucosa by Marshall in ***2.Studies have indicated that the prewence of H.pylori is associated with a variety of gastrointestinal disease including gastritis,duodenal and gastric ulcer,non-ulcer dyspepsia,gastric adenocarcinoma and lymphoma.The organism is present in ****8% of patients with duodenal ulcer and ****0% of patients with gastric ulcers.The studies have also demonstrated that removal of the organism of symptoms and cure of diseases. There are several methods of diagnosing H pylori infection including invasive procedures using mucosa biopsies taken during endoscopy (mainly culture,
histology and the rapid urease test) and noninvasive procedures (mainly *3c or *4 Curea breath tests(UBTs) and serological tests).But invasive procedures suffer form biopsies and endoscopy,and the UBTs require expensive equipment or is harmful to patients.Because H pylori antibody titers fall very slowly even after successful eradication,tests lack of specificity and sensitivity.
Reagents and Materials Provided
1.Individually sealed foil pouches containing:
a.One cassette test device.
b.One desiccant.
2.Sample extraction tubes,each containing 2ml of extraction
buffer.
3.One package insert(instruction for use).